# K091580: Pica Whole Body Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Time Medical Limited
- Decided: Jul 24, 2009 after 52 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K073457 (2008). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073457: Mstar MPD4500, Xinaomdt Technology Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K113281: Mri Sytems (2012), 2 descendants of its own
- K202518: Promaxo MRI System (2021), 1 descendant of its own
- K093984: Pica Whole Body Mri System Model TMS-Mri-3500WB-01 (2010), 1 descendant of its own
- K232361: Promaxo MRI System II (2023), 0 descendants of its own
- K110942: Pica Whole-Body Mri System (2011), 0 descendants of its own

## Indications for use
PiCA is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Pica may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K091580
Methodology: https://510kreport.com/methodology